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Trial to Assess Lacosamide as the First add-on Anti-epileptic Drug Treatment in Patients With Partial-onset Seizures

NCT00955357 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 461

Last updated 2018-07-17

Study results available
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Summary

To evaluate the efficacy and safety of oral Lacosamide as first add on treatment in subjects with uncontrolled partial-onset seizures after prior treatment with a monotherapy Antiepileptic Drug (AED) regimen compared to subjects who have received treatment with at least 2 AEDs.

Conditions

  • Partial Epilepsies

Interventions

DRUG

Lacosamide

Oral Lacosamide: Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet Twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week

Sponsors & Collaborators

  • UCB Pharma

    lead INDUSTRY

Principal Investigators

  • UCB Clinical Trial Call Center · +1 877 822 9493 (UCB)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2013-04-30
Completion
2013-08-31

Countries

  • United States
  • Austria
  • Bulgaria
  • Czechia
  • Denmark
  • Finland
  • France
  • Greece
  • Italy
  • Mexico
  • Romania
  • Russia
  • Spain
  • Switzerland
  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00955357 on ClinicalTrials.gov